Device Recall Gambro

Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.

Gastroenterology-Urology Devices

2

No

Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.

Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.

Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

Gastroenterology-Urology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.

Gastroenterology-Urology Devices

3

No

Worldwide Distribution.

Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box

Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.

Gastroenterology-Urology Devices

3

No

Worldwide Distribution.

Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution.

Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box